PCR Method Approved as Draft International Standard by ISO
The world’s trust in South Korean COVID-19 diagnostic kit manufacturers is expected to be further enhanced once the PCR method for microbial pathogen detection, which has been proposed by South Korea, becomes an international standard. Their exports are likely to skyrocket with the U.S. FDA expected to approve their products soon.
The PCR technique was recently approved as a draft international standard (DIS) by ISO/TC 212. The draft is to define procedures and methods as to nucleic acid amplification-based in-vitro diagnosis applicable to various infectious diseases. The standard can be applied to the real-time PCR method that the manufacturers employ. This means the development of international standards related to in-vitro tools based on that technique will be led by South Korea.
With early diagnosis mentioned as one of the major reasons why South Korea has been successful in dealing with the pandemic, more and more countries around the world are requesting South Korean manufacturers’ kits. The Ministry of Foreign Affairs announced on March 28 that multiple companies’ COVID-19 diagnostic kits obtained prior approvals from the U.S. FDA. Yet as of March 29, no Korean COVID-19 diagnostic kits were included in the FDA list of emergency use authorization (EUA).
Under the circumstances, the South Korean government formed a task force to make public data on requests for South Korean medical supplies and the demand and supply of such supplies. According to the task force, more than 50 countries have made requests or inquiries through diplomatic routes so far. The task force explained that the international demand for COVID-19 diagnostic kits is rising fast as those are capable of coming up with diagnosis results within just six hours and more than 360,000 cases of data are already accumulated with regard to those kits.